NCT03079271Unknown4 期
An Open Label Comparing the Short Term Efficacy of Lacrisert
Virginia Eye Consultants1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dry eye disease measured by Corneal Staining
研究概览
简要总结
To evaluate the short term effects of LACRISERT®. upon fluorescein corneal staining, tear osmolarity and surface topography in human subjects with dry eye disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has Dry Eye disease indicated by a staining score of ≥ 4 and Speed score of >6
排除标准
- •Concurrent involvement in any other clinical trial
- •Anticipated contact lens wear during the study and 14hours prior to Day -History of corneal transplant
- •Active ocular infection, uveitis or non-KCS inflammation
- •History of recurrent herpes keratitis or active disease within the last six months
- •Topical ophthalmic medications during the study
- •Temporary collagen punctal plugs within one week prior to study.
研究组 & 干预措施
open label
Other
干预措施: Lacrisert, 5 Mg Ophthalmic Insert (Drug)
结局指标
主要结局
Dry eye disease measured by Corneal Staining
时间窗: 10 days
Dry eye disease measured by topographic results
时间窗: 10 days
Dry Eye disease measured by OSDI questionnaire
时间窗: 10 days
次要结局
未报告次要终点
研究者
研究点 (1)
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